NCT07607730 · RECRUITING
Regulating Together for Prader-Willi Syndrome: A Group Behavioral Therapy for Emotion Dysregulation
This study tests a group behavioral therapy program called Regulating Together for teens with Prader-Willi Syndrome, a rare genetic condition, and their caregivers. It teaches practical ways to manage irritability, meltdowns, and anxiety. This is an early program-adaptation study with no drug involved, so it is not a proven or approved treatment.
Eligibility criteria
Child Participant Inclusion Criteria: * Ages 13-17.5 years * Confirmed genetic diagnosis of Prader-Willi Syndrome * Fluent in spoken English * Adolescent's use of flexible phrase speech or greater * Meeting clinically significant emotional dysregulation criteria * Willing to participate in weekly 90-minute group sessions * Family is willing to keep prescribed psychiatric medication and outside behavioral interventions stable * Parent, guardian, or legally authorized representative must provide written permission on behalf of the participant Child Participant Exclusion Criteria: * Initiation of new psychosocial intervention within 30 days prior to first day of treatment * Presence of physical aggression in the adolescent directed towards a peer outside the home that resulted in injury within 30 days prior to screening * Presence of comorbid major neuropsychiatric illness warranting other treatment approaches * Presence of any major sensory impairment that would limit participating in the material including blindness or uncorrected hearing loss Caregiver Inclusion Criteria: * Age ≥ 18 years * Lives and cares for their child with PWS for > 50% of the year * Fluent in spoken English * Willing to participate in twice weekly 90-minute sessions, including one virtual session weekly Caregiver Exclusion Criteria: -Presence of any major sensory impairment that would limit participating in the material including blindness or uncorrected hearing loss
The sponsor's own eligibility wording, lightly reformatted. The study team makes the final eligibility decision — worth discussing with your doctor.
Eligibility criteria as of 2026-09-02